Lercanidipine hydrochloride sustained release preparation and preparation method thereof

A technology of lercanidipine hydrochloride and lerca hydrochloride, which can be used in pharmaceutical formulations, drug delivery, cardiovascular system diseases, etc., and can solve problems such as difficulties

Inactive Publication Date: 2010-03-03
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After conventional preparations are taken, the drug concentration rises rapidly to the maximum value, and then decreases rapidly due to metabolism, excretion and degradation. It is difficult to control the drug concentration between the minimum effective concentration and the maximum safe concentration;

Method used

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  • Lercanidipine hydrochloride sustained release preparation and preparation method thereof
  • Lercanidipine hydrochloride sustained release preparation and preparation method thereof
  • Lercanidipine hydrochloride sustained release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Plain Tablet Prescription:

[0037] Lercanidipine Hydrochloride 10g

[0038] Copovidone 20g

[0039] Microcrystalline Cellulose 60g

[0040] Polyethylene glycol 15g

[0041] Hypromellose 80g

[0042] Magnesium Stearate 2g

[0043] Proper amount of ethanol

[0044] Coating Solution Prescription:

[0045] Opadry (Red) 40g

[0046] Appropriate amount of water

[0047]

[0048] Makes 1000 pieces

[0049] Preparation process

[0050] 1 Preparation process of plain tablets

[0051] 1.1 Preparation of dispersion Take the prescribed amount of lercanidipine hydrochloride and copovidone and dissolve them in ethanol to make a 5% (w / w) copovidone ethanol dispersion for subsequent use;

[0052] 1.2 Granulation Put hydroxypropyl methylcellulose, microcrystalline cellulose and polyethylene glycol together into a mixing granulator, mix them, and add copovidone ethanol dispersion for wet granulation after uniformity, take out the granules with a 20...

Embodiment 2

[0060] Plain Tablet Prescription:

[0061] Lercanidipine Hydrochloride 10g

[0062] Ethyl cellulose 80g

[0063] Microcrystalline Cellulose 20g

[0064] Lactose 60g

[0065] Povidone 40g

[0066] Stearic acid 4g

[0067] Proper amount of ethanol

[0068] Coating Solution Prescription:

[0069] Opadry 50g

[0070] Appropriate amount of water

[0071]

[0072] Makes 1000 pieces

[0073] Preparation process

[0074] 1 Preparation process of plain tablets

[0075] 1.1 Preparation of adhesive: Dissolve the povidone of the prescribed amount in ethanol to make a 10% (w / w) adhesive for subsequent use;

[0076] 1.2 Granulation: Sieve lercanidipine hydrochloride and lactose through 80-mesh sieve respectively, put them into a mixing granulator together with ethyl cellulose and microcrystalline cellulose, mix them, and add a binder for wet granulation after uniformity, take out The granules were wet sized with a 20-mesh sieve. After drying, pas...

Embodiment 3

[0082] Plain Tablet Prescription:

[0083] Lercanidipine Hydrochloride 20g

[0084] Carnauba Wax 80g

[0085] Microcrystalline Cellulose 50g

[0086] Sucrose 20g

[0087] Povidone 30g

[0088] Magnesium Stearate 5g

[0089] Proper amount of ethanol

[0090] Makes 1000 pieces

[0091] Coating solution prescription: (1000 tablets dosage)

[0092] Cellulose diacetate 50g

[0093] Polyethylene glycol 6g

[0094] Dibutyl sebacate 4g

[0095] Proper amount of acetone

[0096]

[0097] Makes 1000 pieces

[0098] Preparation process

[0099] 1 Preparation process of plain tablets

[0100] 1.1 Preparation of adhesive: Dissolve the povidone of the prescribed amount in ethanol to make a 5% (w / w) adhesive for subsequent use;

[0101] 1.2 Granulation: After sieving sucrose and microcrystalline cellulose with 80 meshes respectively, put them into the mixing granulator together with lercanidipine hydrochloride and carnauba wax, mix them, and then add...

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PUM

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Abstract

The invention discloses a sustained release medicinal preparation containing lercanidipine hydrochloride, which consists of an effective dose of lercanidipine hydrochloride and pharmaceutically acceptable pharmaceutic adjuvant. The lercanidipine hydrochloride sustained release medicinal preparation prepared can enable the medicament constantly and stably to release in vivo, ensures a steady plasmalevel, and radically improves the safety and effectiveness of the medicament.

Description

technical field [0001] The invention relates to a sustained-release pharmaceutical preparation, in particular to an antihypertensive drug lercanidipine hydrochloride or a physiologically acceptable salt sustained-release pharmaceutical preparation and a preparation method thereof. technical background [0002] Lercanidipine hydrochloride is a third-generation dihydropyridine calcium channel antagonist developed by the Italian company Recordati. It was first launched in the Netherlands in 1997, and then in 18 countries including France, Australia, and Germany. In Europe, this product is used for various types of hypertension, and in the UK it is only used for mild and moderate hypertension. [0003] As a dihydropyridine calcium antagonist, lercanidipine hydrochloride has a basic skeleton of a dihydropyridine ring. In addition, lercanidipine hydrochloride also has a very unique side chain. This side chain has two special groups, one is a hydrophilic protonation group, and its...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/30A61K31/44A61P9/12
Inventor 林鹏李育巧郑顺利
Owner COSCI MED TECH CO LTD
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